Avera To Enroll First Patients in Landmark Lung Cancer Tri-Therapy Clinical Trial

Posted: Monday, January 22, 2018


Sioux Falls,Jan. 19, 2018(GLOBE NEWSWIRE) --

SIOUX FALLS, S.D. — The first patients in the world will be able to enroll in a new cancer study at Avera as part of an international collaboration that looks to transform care for lung cancer patients.

This clinical trial that received the approval of the FDA is Avera’s latest collaboration as part its membership in the Worldwide Innovative Networking (WIN) Consortium.

“We’re taking a bold step in a new direction so lung cancer patients have hope for more treatment options after diagnosis. This latest step in our collaboration with WIN represents one clinical trial but is part of our larger goal to revolutionize cancer care through personalized medicine,” said Benjamin Solomon, MD, the lead investigator for the study at Avera and medical oncologist with Avera Cancer Institute. “If successful, this study could lead to a complete paradigm shift in our approach to lung cancer treatment with a goal of realizing big improvements in outcomes for patients.”

More than 60 percent of non-small cell lung cancer cases are detected in an advanced stage, and less than 5 percent of these patients are alive five years after diagnosis.

In the Survival Prolongation by Rationale Innovative Genomics (SPRING) trial, patients will be given a three-drug protocol that incorporates immunotherapy (avelumab) and two other targeted therapies (palbociclib and axitinib). All patients will be given the same drug combination and their response rates will be tracked to see which patients respond best.

Through the WIN Consortium, an Avera research team under Solomon’s leadership has helped design and implement the clinical trial from the ground up.

“This breakthrough research is happening in Sioux Falls, S.D., because of the high level of expertise and commitment available here,” said Vladimir Lazar, MD, PhD, founder and Chief Scientific and Operating Officer of the WIN Consortium. “With these clinical trials we want to go beyond what is now possible so patients around the world can have more hope when they get a lung cancer diagnosis.”

Because cancer evolves as it grows, it can acquire more genomic complexity over time. DNA sequencing and RNA expression levels in tumor and normal tissues will help guide care by analyzing the patient’s cancer genomic abnormalities to determine the specific changes that have occurred. A multi-drug combination has the potential to treat lung cancer by blocking multiple cancer pathways that develop as a result of these genomic changes.

For the most effective results, researchers work to pair the drug combinations that may work best to combat each lung cancer genomic abnormality. To accomplish this, WIN developed an algorithm, SIMS (Simplified Interventional Mapping System), which is hypothesized to better predict personalized treatment for cancer patients.

The end goal is to pair every lung cancer genomic abnormality with an effective drug combination. This may lead to dozens of clinical trials aimed at accomplishing this goal. In the future, this treatment algorithm could potentially be expanded to other tumor types such as colon or breast cancer.

The SPRING trial will be led by Razelle Kurzrock, MD, (University of California San Diego, Moores Cancer Center) and co-led by Enriqueta Felip, MD, (Vall d'Hebron Institute of Oncology). It will be launched in five countries and eight WIN member sites. Avera, one of two sites in the U.S., is the first to begin enrolling patients.

The SPRING trial will be conducted in two phases. Phase I will explore the safety of the drug combination and determine the optimal doses for Phase II, which will explore the efficacy of this tri-therapy regimen in first-line treatment of metastatic non-small cell lung cancer. The trial will have strict eligibility criteria and limited enrollment.

About Avera Health

Avera Health is an integrated health system comprised of more than 330 locations in 100 communities in a five-state region. A full continuum of care is offered through 32 hospitals, 200+ clinics, retirement communities, home care, sports and fitness centers, with award-winning care in 60+ medical specialties. With more than 17,000 employees and physicians, Avera is the largest private employer in South Dakota. Avera is distinguished through technology and innovation. We are home to the world’s most extensive telemedicine network, and a world-class genomics program that translates the latest cancer research directly to patient care. As a health care ministry, we carry on the legacy of the Benedictine and Presentation Sisters, delivering care in an environment guided by our values of compassion, hospitality and stewardship. For more information about Avera, see our website at Avera.org

About the WIN Consortium

Founded in 2010, WIN is unique structurally in that it brings together organizations from academia, business and not-for-profits to focus on translating the latest advances in personalized cancer medicine into the standard of care. WIN is built on the recognition that all stakeholders in personalized cancer therapy must collaborate and share information, in order to effectively bring the latest innovations in personalized cancer care to the patient. WIN is a non-profit organization formed by 40 renowned members: Academic cancer centers (32 centers in 17 countries), companies (Pfizer, Merck KgaA, Covance, Illumina, HTG Molecular, Blue Cross Blue Shield Association, etc.), non-profit organizations such as Fondation ARC, European Cancer Patient Coalition, SurviveIt. The SPRING trial will be presented during the WIN Symposium “WINning the War against Cancer” in Paris (France) on June 25-26, 2018. For further information, please visit www.winconsortium.org and www.winsymposium.org.

WIN represents a global collaboration of cancer centers, life science and biotech organizations, pharmaceutical and technology companies, health plans, and not-for-profit organizations.
The Worldwide Innovative Networking (WIN) Consortium in personalized cancer medicine was initiated in 2010 with leadership from leading cancer centers worldwide. WIN is a non-profit, non-governmental organization headquartered in Paris.

WIN was created to accelerate the pace and reduce the cost of translating novel cancer treatments to the bedside by developing and applying, through worldwide clinical trials and research projects, the most promising advances in genomic-based cancer research. WIN aims to initiate research projects each year in a global consortium guided by an independent scientific advisory board.

WIN now includes 43 institutional members. These stakeholders have come together from all parts of the world to address the challenge of increasing the efficacy of cancer diagnostics and therapeutics by understanding the genetics and biology of each individual’s tumor and accounting for genetic differences across diverse populations—from North and South America, Europe, Asia, and the Middle East.

Our goal is to significantly improve outcomes for patients around the globe. We aim to increase the number of patients worldwide that have access to innovative, global clinical trials in the area of genomic-based cancer therapeutics. Global diversity and inclusion of all stakeholders is WIN’s most important and differentiating asset.
WIN is comprised of organizations representing all stakeholders in personalized cancer medicine.
WIN enables cross-sector collaborations designed to accelerate the speed and efficacy with which breakthroughs in personalized cancer medicine can be realized and brought to patients worldwide.

Our members include leading academic, pharmaceutical, life science, not-for-profit, health IT, and healthpayer organizations.
Our members include 30 leading academic centers representing 18 countries and four continents, enabling coordinated studies with a global patient population.
The response to a genetically-targeted therapy can vary due to differences in ethnicity and environment. WIN's global studies are designed to identify and account for this variability, enhancing the speed and efficacy with which novel discoveries can be made and brought to patients around the world.

WIN's first trial, WINTHER, is currently being carried out through a collaboration between six academic centers in five countries, with key support from Europe (EUFP7), Fondation ARC, Pfizer and other pharma companies.
WIN prioritizes cross-sector interaction designed to enhance learning across and between continents and healthcare sectors.
WIN Symposia, held annually in Paris, brings together hundreds of leaders representing all stakeholders from around the world in a forum designed to promote the exchange of ideas and information.